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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

Product Description UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler.
Recall Number Z-0652-2013
Classification Class II
Code Info Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
Product Distributed Qty 208 units
Reason For Recall Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.

Event Detail

Event Id 63226
Product Type Devices
Status Ongoing
Recalling Firm Surgical Tissue Network, Inc.
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-14
Initial Firm Notification of Consignee or Public
Distribution Pattern Worldwide Distribution including Turkey, Greece, & Mexico.